Medical devices such as stents, guidewires, catheters, intravascular filters, needles, and needle stylets are used in performing a wide variety of medical procedures within the body. To permit such devices to be inserted into relatively small regions such as the cardiovascular and/or peripheral anatomies, the various components forming the device must be made relatively small while still maintaining a particular performance characteristic within the body such as high flexibility and fatigue strength. In the design of stents, for example, it is desirable to make the struts highly flexible to permit the stent to be easily collapsed and inserted into a deployment device such as a sheath or catheter. The stent must also be resistant to the formation of cracks or other irregularities that can reduce the performance of the device. Crack propagation may occur, for example, in regions of the stent subjected to high tensile stresses such as at joints and bending regions. Repeated expansion and contraction of the device within the body may accelerate the growth of these cracks, reducing the performance of the device over time.
A number of processes have been used to impart flexibility and fatigue strength to the surface of medical devices. Such processes typically include treating the medical device by annealing, work hardening, or other suitable technique to alter the physical characteristics of the material. In a shot peening process, for example, the surface of a workpiece is physically bombarded with particles or shot to form a superficial compressive residual stress region below the surface. The formation of these compressive residual stresses within the workpiece tend to negate the tensile stresses that can cause the initiation and growth of fatigue cracks, and allows the workpiece to undergo a greater amount of bending before plastically deforming.
While conventional processes such as shot peening have been used in treating medical devices, the efficacy of such processes are typically limited by the depth, and in some cases the accuracy, at which the compressive residual stress regions can be formed within the workpiece. In general, the greater the depth at which compressive residual stresses are formed within the workpiece, the greater the resistance to cracking that will result. Since many convention processes such as shot peening are limited by the depth at which the compressive residual stress region can be formed, such processes are not always effective at preventing cracks in highly flexible regions deep within the surface of the workpiece.